Safety & Pharmacovigilance Specialist I
Updated: Yesterday
Location: Gurugram or Hyderabad, India
Job ID: 25104799
Employment Type: Full-Time
About Syneos Health
Syneos Health® is a globally integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative solutions that address today’s evolving healthcare and market challenges.
With a presence across 110 countries and a workforce of more than 29,000 professionals, Syneos Health is driven by a mission to shorten the distance from lab to life while keeping patients at the center of everything we do.
Role Overview
The Safety & Pharmacovigilance (PV) Specialist I plays a critical role in supporting clinical trial and post-marketing safety activities. This position is responsible for end-to-end pharmacovigilance case processing, regulatory compliance, safety database management, and quality review activities in alignment with global regulations and internal SOPs.
This role is ideal for early-career PV professionals seeking to build strong expertise in ICSR processing, regulatory reporting, and safety operations within a global CRO environment.
Key Responsibilities
Pharmacovigilance & Case Processing
Receive, triage, process, and track Individual Case Safety Reports (ICSRs) in accordance with SOPs and project-specific safety plans.
Evaluate case data for completeness, accuracy, and regulatory reportability.
Perform data entry, medical coding (MedDRA, WHO-DD), and narrative writing within safety databases.
Identify missing or unclear information, generate follow-up queries, and ensure timely resolution.
Manage duplicate case identification and reconciliation.
Regulatory & Safety Reporting
Support the preparation and submission of expedited safety reports in compliance with global regulatory requirements.
Maintain safety tracking logs and ensure on-time regulatory submissions.
Apply Syneos Health regulatory intelligence to all safety reporting activities.
Literature & Signal Support
Conduct literature screening and review for safety-relevant cases.
Support drug dictionary maintenance and recoding activities.
Assist in safety signal detection and ongoing risk assessment activities as required.
Data Standards & Systems
Validate and submit xEVMPD product records, including MedDRA-coded indication terms.
Perform manual recoding of product and substance terms arising from ICSRs.
Support SPOR and IDMP-related pharmacovigilance activities.
Quality & Compliance
Perform quality review of ICSRs and safety documentation.
Ensure accurate and timely filing of safety documents in the Trial Master File (TMF) and Pharmacovigilance System Master File (PSMF).
Maintain compliance with SOPs, Work Instructions, ICH-GCP, ICH-GVP, and global regulatory requirements.
Participate in internal and external audits as required.
Collaboration
Build and maintain effective working relationships with cross-functional teams, sponsors, and external stakeholders.
Contribute to a collaborative, quality-driven, and patient-focused work environment.
Required Qualifications
Education
Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm / PharmD) or BDS
Experience
Minimum 2 years of hands-on experience in Pharmacovigilance or Drug Safety
Experience in clinical trial case processing (CT) and/or literature case processing preferred
Technical & Professional Skills
Strong knowledge of ICSR processing, safety databases, and medical terminology
Good understanding of clinical trial phases (II–IV) and/or post-marketing safety
Working knowledge of ICH-GCP, GVP, and global pharmacovigilance regulations
Experience with MedDRA coding, safety workflows, and PV quality standards
Proficiency in Microsoft Office (Word, Excel, PowerPoint), Outlook, and shared document platforms
Soft Skills
Excellent written and verbal communication skills
Strong organizational and time-management abilities
High attention to detail and commitment to data quality
Ability to work independently and collaboratively in a global environment
Why Join Syneos Health
Global exposure across clinical trials and post-marketing programs
Structured career development and continuous learning opportunities
Supportive leadership and inclusive workplace culture
Opportunity to work on therapies impacting patients worldwide
Over the past five years, Syneos Health has supported:
94% of all novel FDA-approved drugs
95% of EMA-authorized products
200+ studies across 73,000 sites and 675,000+ trial patients
Additional Information
Job responsibilities listed are not exhaustive and may evolve based on business needs. Syneos Health is an equal opportunity employer and is committed to compliance with all applicable employment and disability regulations. Reasonable accommodations will be provided as required.
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